Using Mirabegron to Control Arrhythmia-1

Objectives:

Primary objective: To evaluate if mirabegron can reduce the VT burden. Secondary objective: To test the hypothesis that mirabegron can reduce the average skin sympathetic nerve activity (aSKNA).

Endpoints: The primary endpoint is the burden of VT detected by ICD. The secondary endpoint is the average skin sympathetic nerve activity, symptoms, and quality of life (QOL) questionnaires.

Study Population: This is a pilot study in patients with an ICD and, on average, > 2 episodes of VT per month over the past 2 months despite guideline-recommended medical therapy (GRMT).

Phase: Phase 2.

Description of Sites/Facilities Enrolling Participants: The investigators will enroll patients in the cardiac device clinic at the Smidt Heart Institute, Cedars-Sinai Medical Center. Dr. Ashkan Ehdaie (co-investigator) directs the clinic, which routinely follows up on patients with ICDs.

Description of Study Intervention: The investigators will give the patients 50 mg/day of mirabegron orally for three months.

Study Duration: One-year.

Participant Duration: Approximately three months. The primary endpoint takes 2 months to complete. The investigators will call the patient at 3 months to determine if there are any complications. The patient will then exit the study.

Inclusion criteria

• In order to be eligible to participate in this study, an individual must meet all the following criteria:

• Provision of signed and dated informed consent form.
• Age > 18 years old.
• Documented VT on ICD.

• with > 2 episodes of VT per month (on average) over the past 2 months.
• despite guideline-recommended medical therapy (GRMT).

Exclusion criteria

• An individual who meets any of the following criteria will be excluded from participation in this study:

• Patients who are pacemaker-dependent because the pacing artifacts will complicate skin sympathetic nerve activity (SKNA) analysis.
• Clinically unstable (for example, acute myocardial infarction, decompensated heart failure, undergoing cancer chemotherapy, and other acute illness requiring hospitalization)
• Uncontrolled hypertension (systolic blood pressure ≥180 mm Hg or diastolic blood pressure ≥110 mm Hg, or both)25
• Active thyrotoxicosis
• Any experimental medication concomitantly or within 4 weeks of participation in the study
• Currently participating in a different clinical trial
• Severe renal impairment (CrCl < 30 ml/min)
• Hepatic disease (Child-Pugh Class C)
• Pregnant
• Breastfeeding
• Cannot speak, write, and answer questions in English
• Does not have the capacity to consent
• Severe renal impairment (CrCl < 30 ml/min)
• Hepatic disease (Child-Pugh Class C)
• Pregnant
• Breastfeeding
• Cannot speak, write, and answer questions in English
• Does not have the capacity to consent
• Patients who are known to be allergic to mirabegron or skin patch electrodes
• Patients taking codeine, oxycodone, thioridazine, flecainide, propafenone, and digoxin. (see explanation below)